Results from a Phase-II Dual Stem Cell Trial

Back in 2011, when this clinical trial was registered, I was not careful about blogging on all the new research.  Somehow I completely missed this study. So this is my first blog posting on this research.

The Clinical Trial

This trial was testing the impact of giving two different stem cell treatments at the same time.   The people in this trial had long established type-1 diabetes.   No long term immunosuppression was used. The study was randomized and controlled, but was not blinded. The researchers and the patients both knew who was getting the treatment and who was not.  A total of 21 people were treated and they were compared to 21 people not treated.  This paper reports on data gathered for a year after treatment.

The people were all adults, and had been diagnosed (on average) for 7 to 10 years.  Everyone had type-1 diabetes for at least 2 years when the trial started.  The clinical trial record describes it as phase-I / II, but the paper calls it a "pilot trial".  Based on size I'm calling it a phase-I trial.  But it's large for a phase-I trial.

The treated people were given two types of stem cells:

• Stem cells harvested from the umbilical cord.  Everyone got stem cells from the same umbilical cord.  These are called "umbilical cord mesenchymal stromal cells" (UC-MSCs).

• Stem cells "self donated" from the patient's own bone marrow.  These are called "autologous bone marrow mononuclear cells" (aBM-MNC).

The Results

The following two graphs include the most important results, from my point of view.  The F graph shows fasting c-peptide levels. The A graph shows c-peptide levels 3 hours after a meal.  In both cases, higher numbers are better.  C-peptide is generated when the body produces it's own insulin, so these graphs show the body generating about twice as much insulin in two different situations.

In addition, they measured A1c and insulin usage, plus some psychological measurements of happiness and number of low BG instances.

Discussion

The results here are much stronger than the positive results that I've seen in other trials, and the fact that these results are seen in long established type-1 diabetics makes them all the stronger.  The treated patients generated about twice as much C-peptide at the end of the trial as at the beginning. For an oversimplified comparison to other clinical trials done on long established type-1 diabetics:

• This study:  100% more C-peptide
• Stem Cell Educator: very roughly 100% more C-peptide
• TOL-3021: 28% more C-peptide
• BCG: 22% more C-peptide

It's important to remember that since all of these people were established type-1 diabetics, they were generating very little C-peptide of their own to start with, so twice a small amount is still a small amount.

The treated group's insulin usage dropped about 30% (while their A1c levels dropped also!).   You could argue that these researchers are 30% of the way to a cure, although that does oversimplify things.  Again, an oversimplified comparison to other clinical trials done on long established type-1 diabetics:

• This study: 30% less insulin
• Stem Cell Educator: 25% or 38% less insulin
• TOL-3021: not measured.
• BCG: not measured.

All of this is good news, and similar to Stem Cell Educator results, which (up until now) have been the absolute best results seen in long established type-1 diabetics.

Conference Abstract:
http://conference.idf.org/IDF2015/CM.NET.WebUI/CM.NET.WEBUI.SCPR2/SCPRfunctiondetail.aspx?confID=05000000-0000-0000-0000-000000000003&sesID=05000000-0000-0000-0000-000000001276&absID=07000000-0000-0000-0000-000000008843
Paper Abstract: http://care.diabetesjournals.org/content/early/2015/11/29/dc15-0171.abstract
Full Paper: http://care.diabetesjournals.org/content/early/2015/11/29/dc15-0171.full.pdf
Clinical Trial Registry: https://clinicaltrials.gov/ct2/show/NCT01374854


Joshua Levy 
http://cureresearch4type1diabetes.blogspot.com 
publicjoshualevy at gmail dot com
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.